KEY TAKEAWAYS
- The phase II trial aimed to present the updated results on the efficacy and safety of anlotinib plus irinotecan or docetaxel in pts with relapsed SCLC.
- The study’s primary endpoint was the ORR. Secondary endpoints included PFS, DCR, OS, and safety.
- The study found that anlotinib plus irinotecan or docetaxel showed better efficacy and safety than standard chemotherapy for non-sensitive recurrent SCLC.
Anlotinib is a promising new advanced small-cell lung cancer (SCLC) treatment that relapsed within 6 months after first-line treatment. This has shown better progression-free survival (PFS) and overall survival (OS) than chemotherapy alone in the ALTER 1202 trial.
Researchers aimed to present the updated results on the efficacy and safety of anlotinib plus irinotecan or docetaxel in patients (pts) with relapsed SCLC within 6 months of first-line treatment.
Pts received anlotinib (12mg, QD from day 1 to 14 of a 21-day cycle, dose adjustable to 10mg or 8mg based on tolerance) along with either irinotecan (65mg/m2, day1,8, q3w, up to 4 cycles) or docetaxel (60mg/m2, q3w, up to 4 cycles) until disease progression or intolerable side effects. The primary endpoint was the objective response rate (ORR), while secondary endpoints were PFS, disease control rate (DCR), OS, and safety.
The study included 39 pts, 36 eligible for efficacy analysis (median age: 63.2 years, male: 86.1%, ECOG PS 1: 80.6%, brain metastasis: 58.3%, liver metastasis: 36.1%). The median follow-up was 17.2 months (95% CI, 8.27 – 26.13). Among the 36 evaluable pts, 1 achieved complete response (CR), 20 had partial response (PR), and 11 showed stable disease (SD). ORR was 58% (21/36), and DCR was 89% (32/36). Median PFS was 4.4 months (95% CI: 3.73 – 5.08), and median OS was 7.9 months (95% CI: 5.28 – 10.52). Pts with recurrence >3 months and ≤6 months after first-line therapy showed more significant improvements in PFS at 6.5 months and OS at 11.9 months compared to those with recurrence ≤ 3 months, PFS at 4.1 months and OS at 5.9 months. The most common grade 1-2 treatment-related adverse events (TRAEs) included weakness (58.3%), anorexia (38.9%), anemia (25%), hypertension (15.6%), oral mucositis (13.9%), and leukopenia (11.1%). Three patients (8.3%) experienced grade 3 AEs, including thrombocytopenia, leukopenia, and anemia.
The study found that anlotinib plus irinotecan or docetaxel showed better efficacy and safety than standard chemotherapy for non-sensitive recurrent SCLC.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.e20629
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04757779
Minna Zhang, Xueqin Chen, Hong Jiang, Jiaoli Wang, Jian Ye, Shenglin Ma, and Bing Xia. DOI: 10.1200/JCO.2023.41.16_suppl.e20629 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) e20629-e20629.
